The Initial Steps Toward Understanding GMP for Drugs: 3

1. Introduction

In the previous article, I looked into ICH Q10 Pharmaceutical Quality System, a guideline covering the whole process of drugs from development to manufacturing and quality control, prepared based on ISO 9001. In this article, I would like to discuss a quality system from the GMP perspective and the importance of system inspections.

2. Pharmaceutical Quality System Defined by the FDA

The Food and Drug Administration (FDA) was the first organization presented the concept of the Pharmaceutical Quality System (PQS). That happened in 2002, years before the publication of ICH Q10. In the context of the PQS, the FDA published FDA Compliance Program Guidance Manual 7356.002 on Drug Manufacturing Inspections in 2002 (revised in 2022). In the manual, specifically in 2.B. Inspection of Systems, the following 6 sub-systems are clearly presented:

　1. Quality System
　2. Facilities and Equipment System
　3. Materials System
　4. Production System
　5. Packaging and Labeling System
　6. Laboratory Control System

An US-based multinational pharmaceutical company where I used to work had 8 systems in total by adding two other systems: Sterility Assurance System, and Computerized System. Nowadays those 6 systems are widely accepted as a quality assurance/GMP system by companies in the US and other countries with some creativity in some cases like the company mentioned earlier did. For GMP audits done by overseas companies, the protocol often has chapters according to these 6 sub-systems. Or, some of overseas companies apply those sub-systems into their Site Master File structure in that order.

The 6 system principle is basically developed by the FDA. However, we can see that the EU GMP applies the same principle and that many of recently-merged European/US companies are often required to employ such FDA's principles for their policies. Therefore, we can say that the 6 system principle is now employed globally.
Now, let's focus on the Quality System and take a look at the GMP ministerial ordinance issued in Japan.